A Phase 3 Randomized Study Comparing JNJ-79635322 and an Anti-BCMAxCD3 Bispecific Antibody in Participants With Relapsed or Refractory Multiple Myeloma Who Have Received at Least 3 Prior Lines of Therapy Including a PI, an IMiD, and an Anti CD38 Antibody

Official Summary

The purpose of this study is to evaluate how well JNJ-79635322 works when compared with an anti-B-cell maturation antigen (BCMA)xCD3 bispecific antibody.

Eligibility Requirements

• Minimum Age: 18 Years

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: NONE
• Enrollment: 400 participants

Study Arms

• JNJ-79635322 (EXPERIMENTAL)
  Participants will receive subcutaneous (SC) dose of JNJ-79635322 until progressive disease (PD) or intolerable toxicity.
• Anti BCMAxCD3 Bispecific Antibody (ACTIVE_COMPARATOR)
  Participants will receive teclistamab (an Anti BCMAxCD3 bispecific anitbody) as a SC injection until PD or intolerable toxicity.

Interventions

• DRUG: JNJ-79635322 — JNJ-79635322 will be administered as SC injection.
• DRUG: Teclistamab — Teclistamab will be administered as SC injection.

Primary Outcomes

• Overall Response Rate (ORR) (Up to 5 years and 4 months)
• Progression-Free Survival (PFS) (Up to 5 years and 4 months)

Secondary Outcomes

• Very Good Partial Response (VGPR) or Better (Up to 5 years and 4 months)
• Complete Response (CR) or Better (Up to 5 years and 4 months)
• Duration of Response (DoR) (Up to 5 years and 4 months)
• Minimal Residual Disease (MRD)-negative CR (Up to 5 years and 4 months)
• MRD-negative CR at 9 months (9 months)

Eligibility Criteria

Inclusion:

* Documented diagnosis of multiple myeloma (MM) as defined by the criteria below:

  1. MM diagnosis according to the international myeloma working group (IMWG) diagnostic criteria
  2. Measurable disease at screening as assessed by central laboratory
* Received at least 3 prior lines of antimyeloma therapy including a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-cluster of differentiation (CD)38 antibody
* Documented evidence of progressive disease (PD) or failure to achieve a response (that is partial response \[PR\] or better) to the last line of therapy based on investigator's determination of response by IMWG criteria
* Have discontinued concurrent use of any other anticancer treatment (including nonpalliative radiotherapy) or investigational agent
* Have an eastern cooperative oncology group (ECOG) performance status of 0 to 2 at screening and immediately before the start of study treatment administration

Exclusion:

* Active hepatitis of infectious origin
* Known active or prior central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of MM
* Suspected or known allergies, hypersensitivity, or intolerance to the excipients of JNJ-79635322 and Teclistamab
* Major surgery , (example, requiring general anesthesia) within 2 weeks before first dose, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study
* Received or plans to receive any live, attenuated vaccine within 4 weeks before the first dose of study treatment, during, or within 90 days after the last dose of study treatment

Trial Locations

• USC Norris Comprehensive Cancer Center, Los Angeles, California, United States
• University of Connecticut Health Center, Farmington, Connecticut, United States
• Yale Cancer Center, New Haven, Connecticut, United States
• Florida Cancer Specialists & Research Institute, Fort Myers, Florida, United States
• Moffit Cancer center, Tampa, Florida, United States
• Emory University, Atlanta, Georgia, United States
• University of Iowa Hospital and Clinics, Iowa City, Iowa, United States
• Mission Cancer Blood, Waukee, Iowa, United States
• Norton Cancer Institute, Louisville, Kentucky, United States
• Mount Sinai Brooklyn, Brooklyn, New York, United States
• ...and 10 more locations

Contact Information

• Study Contact — CONTACT
  Phone: 844-434-4210
  Email: Participate-In-This-Study1@its.jnj.com

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